1.Albumin-bound paclitaxel plus anlotinib in patients with recurrent, platinum-resistant primary epithelial ovarian cancer (A-Plus): a phase II, single-arm, prospective study.
Yun ZHOU ; Jian ZHOU ; Yin WANG ; Ji-Bin LI ; Rongzhen LUO ; Chanjuan ZENG ; Yingxin HE ; Yanfang LI
Frontiers of Medicine 2025;19(5):820-830
This study aimed to evaluate the efficacy and safety of combining albumin-bound paclitaxel (abpaclitaxel) and anlotinib for ovarian cancer. In this study, 44 patients diagnosed with platinum-resistant ovarian cancer were enrolled. Patients received ab-paclitaxel along with anlotinib until disease progression or intolerable toxicity. Efficacy was assessed according to RECIST 1.1 criteria or Rustin's criteria. The primary endpoint was the investigator-evaluated objective response rate (ORR). 44 patients were enrolled between January 2021 and March 2023 with a median age of 49 years. Twenty-nine had measurable lesions and 15 had non-measurable lesions. Overall, the investigator-evaluated ORR was 56.8% (25/44; 95% CI 0.411-0.713) in intention-to-treat population and 58.1% (25/43; 95% CI 0.422-0.726) in per-protocol population. The median progression-free survival was 9.8 months, and the median duration of response was 7.4 months. For safety, grade 3/4 adverse events (AEs) included leukopenia, gum pain, hypertension, and hand-foot syndrome. The response rates were 55.0% (11/20) in patients with previous use of antiangiogenic reagents and who had previous use of PARP inhibitors. The combination of ab-paclitaxel and anlotinib showed promising anti-tumor activity and a manageable safety profile in platinum-resistant ovarian cancer. Patients with previous use of antiangiogenic drugs or PARP inhibitors still benefited from this protocol.
Humans
;
Female
;
Middle Aged
;
Indoles/therapeutic use*
;
Quinolines/therapeutic use*
;
Carcinoma, Ovarian Epithelial/drug therapy*
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Adult
;
Ovarian Neoplasms/drug therapy*
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Prospective Studies
;
Antineoplastic Combined Chemotherapy Protocols/administration & dosage*
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Aged
;
Drug Resistance, Neoplasm
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Albumin-Bound Paclitaxel/therapeutic use*
;
Neoplasm Recurrence, Local/drug therapy*
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Progression-Free Survival
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Paclitaxel/administration & dosage*
;
Treatment Outcome
2.Mingshi Formula (明视方) for Low Myopia in Children with Heart Yang Insufficiency Syndrome: A Multicentre, Double-Blind, Randomised Placebo-Controlled Study
Jianquan WANG ; Xinyue HOU ; Zefeng KANG ; Yingxin YANG ; Xinquan LIU ; Zhihua SHEN ; Xiaoyi YU ; Jing YAO ; Fengming LIANG ; Fengmei ZHANG ; Jingsheng YU ; Ningli WANG ; Man SONG ; Hongrui SUN ; Xin YAN
Journal of Traditional Chinese Medicine 2024;65(6):587-593
ObjectiveTo observe the effectiveness and safety of the Chinese herbal medicine Mingshi Granules (明视方颗粒) for low myopia in children with heart yang insufficiency. MethodsA multicentre, prospective, double-blind randomised controlled study was conducted, in which 290 children with low myopia from 8 centres were randomly divided into 145 cases in the treatment group and 145 cases in the control group, and the treatment group was given education, dispensing glasses, and Chinese herbal medicine Mingshi Granules, while the control group was given education, dispensing glasses, and granules placebo. Both Mingshi Granules and placebo granules were taken orally, 1 bag each time, twice daily, 4 weeks of oral intake and 2 weeks of rest as 1 course of treatment, a total of 4 courses of treatment (24 weeks). Equivalent spherical lenses, best naked-eye distance visual acuity, ocular axis, corneal curvature K1, adjustment amplitude, traditional Chinese medicine (TCM) symptom scores, calculate the amount of progression of equivalent spherical lenses, were observed at the 12th and the 24th week of treatment, at the 36th week and 48th week of follow-up, resectively, the control rate of myopia progression was evaluated at the 24th week, and safety indexes were observed before treatment. ResultsThe amount of progression of equivalent spherical lenses was lower in the treatment group than in the control group at the 48-week follow-up (P<0.05). The control rate of myopia progression at 24 weeks after treatment in the treatment group was higher (57.60%, 72/125) than that in the control group (44.63%, 54/121) (P<0.05). The best naked-eye distance visual acuity at 36-week follow-up in the treatment group was higher than that in the control group (P<0.05). Equivalent spherical lenses were significantly lower in both groups at all observation time points compared with pre-treatment (P<0.05), and were higher in the treatment group than in the control group at the 48-week follow-up (P<0.05). The ocular axes of both groups were significantly higher at each observation time point after treatment and at follow-up compared with before treatment (P<0.05). The amount of eye axis growth in the treatment group was lower than that in the control group at 24 weeks after treatment and at the 48-week follow-up (P<0.05). Corneal curvature K1 was significantly lower in the treatment group at the 24th week of treatment compared to pre-treatment (P<0.05). The magnitude of adjustment in the treatment group was significantly higher at the 36-week follow-up and at the 48-week follow-up than before treatment (P<0.05). The scores of white/dark complexion, white coating thin pulse, fatigue and total TCM symptom scores of children in both groups at the 12th, 24th, 36th and 48th weeks of follow-up were significantly lower than those before treatment (P<0.05); the scores of blurred vision at the 24th and 36th weeks of follow-up were significantly lower than those before treatment (P<0.05); and the scores of blurred vision in the treatment group at the 48th week of follow-up were signi-ficantly lower than those before treatment (P<0.05). In the treatment group, the score of fatigue was higher than that of the control group at the 36-week follow-up, and the score of blurred vision was lower than that of the control group at the 48-week follow-up (P<0.05). No adverse reactions or obvious abnormalities of the safety indexes were observed of the two groups during the treatment. ConclusionChinese herbal medicine Mingshi Granules showed the effect of controlling the progression of low myopia, improving the best naked eye distance visual acuity, slowing down the growth of the eye axis, improving some of the TCM symptoms, with good safety.
3.Evaluation of Simulated Weightlessness Model of Hindlimb Unloading Miniature Pigs and Their Tissue Damage
Yingxin TU ; Yilan JI ; Fei WANG ; Dongming YANG ; Dongdong WANG ; Zhixin SUN ; Yuexin DAI ; Yanji WANG ; KAN GUANGHAN ; Bin WU ; Deming ZHAO ; Lifeng YANG
Laboratory Animal and Comparative Medicine 2024;44(5):475-486
Objective To establish a weightlessness simulation animal model using miniature pigs, leveraging the characteristic of multiple systems’ tissue structures and functions similar to those of humans, and to observe pathophysiological changes, providing a new method for aerospace research. Methods Nine standard-grade miniature pigs were selected and randomly divided into an experimental group (n=7) and a control group (n=2). The experimental group was fixed using customized metal cages, with canvas slings suspending their hind limbs off the ground, and the body positioned at a -20° angle relative to the ground to simulate unloading for 30 days (24 hours a day). Data on body weight, blood volume, and blood biochemistry indicators were collected at different time points for statistical analysis of basic physiological changes. After the experiment, the miniature pigs were euthanized and tissue samples were collected for histopathological observation of the cardiovascular, skeletal and muscle systems HE and Masson staining. Statistical analysis was also conducted on the thickness of arterial vessels and the diameter of skeletal muscle fibers. Additionally, western blotting was employed to detect the expression levels of skeletal muscle atrophy-related proteins, including muscle-specific RING finger protein 1 (MuRf-1) and muscle atrophy F-box (MAFbx, as known as Atrogin-1), while immunohistochemistry was used to detect the expression of glial fibrillary acidic protein (GFAP), an indicator of astrocyte activation in the brain, reflecting the pathophysiological functional changes across systems. Results After hindlimb unloading, the experimental group showed significant decreases in body weight (P<0.001) and blood volume (P<0.01). During the experiment, hemoglobin, hematocrit, and red blood cell count levels significantly decreased (P<0.05) but gradually recovered. The expression levels of alanine aminotransferase and γ-glutamyltransferase initially decreased (P<0.05) before rebounding, while albumin significantly decreased (P<0.001) and globulin significantly increased (P<0.01). Creatinine significantly decreased (P<0.05). The average diameter of gastrocnemius muscle fibers in the experimental group significantly shortened (P<0.05), with a leftward shift in the distribution of muscle fiber diameters and an increase in small-diameter muscle fibers. Simultaneously, Atrogin-1 expression in the gastrocnemius and paravertebral muscles significantly increased (P<0.05). These changes are generally consistent with the effects of weightlessness on humans and animals in space. Furthermore, degenerative changes were observed in some neurons of the cortical parietal lobe, frontal lobe, and hippocampal regions of the experimental group, with a slight reduction in the number of Purkinje cells in the cerebellar region, and a significant enhancement of GFAP-positive signals in the hippocampal area (P<0.05). Conclusion Miniature pigs subjected to a -20° angle hind limb unloading for 30 days maybe serve as a new animal model for simulating weightlessness, applicable to related aerospace research.
4.Risk factors for lower extremity deep venous thrombosis in patients with bone trauma and analysis of their diagnostic efficacy
Ting ZHAO ; Yingxin SUN ; Wuwen ZHANG ; Siyuan ZHOU ; Xindie ZHOU ; Tongbao FENG ; Ping ZHANG
Chinese Journal of Trauma 2024;40(9):809-816
Objective:To investigate the risk factors for lower extremity deep vein thrombosis (DVT) in patients with bone trauma and their diagnostic efficacy.Methods:A retrospective cohort study was conducted to analyze the clinical data of 108 patients with bone trauma who were admitted to Affiliated Changzhou Second People′s Hospital of Nanjing Medical University from October 2023 to February 2024, including 61 males and 47 females, aged 17-96 years [(55.2±19.5)years]. Based on the results of color Doppler ultrasonography of lower extremities within 96 hours on admission, the patients were divided into DVT group ( n=58) and non-DVT group ( n=50). In DVT group, 42 patients developed lower extremity DVT within 7 days after trauma and the other 16 patients developed lower extremity DVT after 7 days. Basic clinical data including gender, age, body mass index (BMI), underlying diseases, cause of injury, site of fracture, surgery and admission Caprini score, and admission laboratory test indicators including routine coagulation indicators [prothrombin time (PT), international normalized ratio (INR), thrombin time (TT), activated partial thromboplastin time (APTT), fibrinogen (FBG) and D-dimer (D-D)] and four thrombosis indicators [plasma thrombin-antithrombin III complex (TAT), thrombomodulin (TM), tissue-type plasminogen activator-inhibitor 1 complex (tPAIC) and plasmin-alpha2-plasmin inhibitor complex (PIC)] were collected in the two groups. Univariate analysis and multivariate binary Logistic regression analysis were conducted to investigate the correlation between these indicators and incidence of lower extremity DVT in patients with bone trauma and determine the independent risk factors. Receiver operating characteristic (ROC) curve and area under the curve (AUC) of the relevant risk factors were analyzed to evaluate and compare the diagnostic efficacy of the factors for lower extremity DVT in patients with bone trauma and further assess the diagnostic efficacy of the factors for lower extremity DVT within 7 days after bone trauma. Results:Univariate analysis revealed significant correlations of gender, age, Caprini score, D-D, TAT, TM and PIC with incidence of lower extremity DVT in patients with bone trauma ( P<0.01). The results of multivariate binary Logistic regression analysis demonstrated that Caprini score ( OR=1.36, 95% CI 1.12, 1.65, P<0.01), TAT ( OR=1.05, 95% CI 1.00, 1.10, P<0.05), and TM ( OR=1.34, 95% CI 1.02, 1.77, P<0.05) were significantly correlated to incidence of lower extremity DVT in patients with bone trauma. ROC curve analysis indicated that TAT (AUC=0.76, 95% CI 0.67, 0.86) had the highest diagnostic efficiency, followed by TM (AUC=0.72, 95% CI 0.62, 0.81) and Caprini score (AUC=0.72, 95% CI 0.62, 0.82). The combined analysis of all the factors effectively enhanced the diagnostic efficiency for DVT (AUC=0.84, 95% CI 0.77, 0.92). Additionally, TAT (AUC=0.81, 95% CI 0.71, 0.91) demonstrated better diagnostic efficacy for lower extremity DVT within 7 days after bone trauma compared with the Caprini score (AUC=0.72, 95% CI 0.61, 0.83) and TM (AUC=0.71, 95% CI 0.60, 0.83). Similarly, the combined analysis of all the factors also effectively enhanced the overall diagnostic efficacy for lower extremity DVT within 7 days after bone trauma (AUC=0.85, 95% CI 0.77, 0.93). Conclusions:Caprini score, TAT and TM are identified as independent risk factors for lower extremity DVT in patients with bone trauma, and all the three factors demonstrate good diagnostic efficacy. Their combination is found to have statistically significant higher diagnostic efficiency than each individual factor. Furthermore, TAT is proved to be the best in diagnosing lower extremity DVT within 7 days after bone trauma, while the combined analysis of all the risk factors can further improve the diagnostic efficacy.
5.Long-Term Exposure to Low-Level Ambient Air Pollution and Mortality among 0.3 Million Chinese Older Adults.
Likun LIU ; Xueli YUAN ; Wenqing NI ; Jing WEI ; Tingting LIU ; Ruijun XU ; Yingxin LI ; Zihua ZHONG ; Yi ZHENG ; Sihan LIANG ; Rui WANG ; Jian XU ; Yuewei LIU
Biomedical and Environmental Sciences 2024;37(12):1362-1372
OBJECTIVE:
Evidence that long-term exposure to ambient air pollution increases mortality among older adults, particularly those residing in low-level air pollution locations, remains scarce. This study investigated the potential links between long-term low-level air pollution exposure and mortality among Chinese older adults.
METHODS:
A population-based study with 317,464 individuals aged ≥ 65 years was conducted in Shenzhen, China during 2018 and 2020. Logistic regression models were used to analyze the associations between long-term exposure to air pollution and all-cause mortality, as the primary outcome, as well as non-accidental, cancer and cardiovascular mortality.
RESULTS:
Significant associations of PM 1, PM 2.5, PM 10, SO 2, CO, and O 3 exposures with a higher risk of all-cause mortality were found. Adjusted odds ratio ( OR) for each 1 µg/m 3 increment was 1.49 [95% confidence interval ( CI): 1.46, 1.53] for PM 1, 1.30 (1.27, 1.32) for PM 2.5, 1.05 (1.04, 1.06) for PM 10, 5.84 (5.39, 6.32) for SO 2, 1.04 (1.04, 1.05) for CO, and 1.02 (1.00, 1.03) for O 3, respectively. Long-term PM 1, PM 2.5, PM 10, SO 2, and CO exposures also elevated the risks of non-accidental, cancer and cardiovascular mortality.
CONCLUSION
Long-term low-level air pollution exposure was associated with an increased mortality risk among Chinese older adults.
Humans
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Aged
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China/epidemiology*
;
Male
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Female
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Air Pollution/adverse effects*
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Environmental Exposure/adverse effects*
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Air Pollutants/analysis*
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Aged, 80 and over
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Particulate Matter/adverse effects*
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Cardiovascular Diseases/mortality*
;
Mortality
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Neoplasms/mortality*
;
East Asian People
6.Contrastive analysis on difference of chemical compositions of single decoction and mixed decoction of Gypsum Fibrosum-Anemarrhenae Rhizoma medicinal pair with different proportion
Yingxin ZHOU ; Yao HUANG ; Xiaoxuan YAO ; Tian TIAN ; Jiaming LIN ; Jianyan SUN ; Zhipeng ZHANG ; Dongmei SUN
International Journal of Traditional Chinese Medicine 2023;45(10):1281-1287
Objective:To compare the difference of chemical compositions of single decoction and mixed decoction of Gypsum Fibrosum - Anemarrhenae Rhizoma medicinal pair with different proportion.Methods:The Ultra Performance Liquid Chromatography (UPLC) and Ion Chromatography (IC) fingerprints of each sample were collected, and the independent sample t-test on the ratio of "peak area/weight" value of common peaks which was from the single decoction and mixed decoction samples was performed through SPSS 26.0.Results:In the UPLC fingerprint, there was significant difference in the "peak area/weight" values of peak 1, peak 2, peak 3, peak 6 and peak 13 between mixed decoction and single decoction with different compatibility ratios (1:1, 3:2, 2:1, 5:2, 3:1)( P<0.05), while peak 5 and peak 11 were without significant difference ( P>0.05). When the compatibility ratio of Gypsum Fibrosum and Anemarrhenae Rhizoma was 1:1, 3:2, 5:2, 3:1, there was significant difference in the "peak area/weight" values of peak 7 (neomangiferin) ( P<0.05). In the IC fingerprint, there was significant difference in the "peak area/weight" values of peak 1 between mixed decoction and single decoction with different compatibility ratios (1:1, 3:2, 2:1, 5:2, 3:1) ( P<0.05), while there was no significant difference in peak 5 (calcium ion) ( P>0.05). Conclusion:There are differences in the chemical component content of Gypsum Fibrosum-Anemarrhenae Rhizoma medicinal pair for single decoction and mixed decoction.
7.Systematic evaluation of acute herpes zoster treatment with fire needle therapy mainly
Xinqiao CHU ; Hongmei LIU ; Yufeng GUO ; Ning GAO ; Peichu ZHANG ; Yingxin SUN
International Journal of Traditional Chinese Medicine 2023;45(10):1307-1312
Objective:To systematically evaluate the clinical efficacy of fire needle therapy and conventional western medicine in the treatment of patients with acute herpes zoster.Methods:Randomized controlled trials (RCTs) of fire needle therapy in the treatment of acute herpes zoster were retrieved from China National Knowledge Internet (CNKI), Wanfang, Database of Chinese Sci Tech Periodicals (VIP Database), China Biomedical Literature Database (CBM), Medline, Embase, and Cochrane Library from the establishment of the databases to May 30, 2022. According to the inclusion and exclusion criteria, the included literature was screened, and Review Manager 5.3 was used for system evaluation and meta-analysis.Results:7 articles were included for analysis after screening, involving 452 patients. There were 226 cases in the treatment group and 226 cases in the control group. The results of meta-analysis showed that fire needle therapy was superior to conventional western medicine in the total effective rate [ RR=0.36, 95% CI (0.20, 0.65), P=0.000 7], lower incidence of PHN [ RR=0.25, 95% CI (0.09, 0.72), P=0.01], lower VAS score [ MD=-1.19, 95% CI (-2.14, -0.24), P=0.01], and shorter scab forming time [ MD=-2.03, 95% CI (-2.42, -1.64), P<0.001]. Conclusion:The curative effect of fire needle therapy is more prominent than that of conventional western medicine in the treatment of acute herpes zoster.
8.A retrospective cohort study of case fatality rate of HIV/AIDS cases and influencing factors in Jingzhou, Hubei Province, 1996-2021
Maowen LIN ; Yingxin PEI ; Qingfeng CHEN ; Rui LIU ; Chun SUN ; Zhihui DOU
Chinese Journal of Epidemiology 2023;44(9):1369-1375
Objective:To analyze the case fatality rate of HIV/AIDS cases and influencing factors in Jingzhou.Methods:The data were retrieved from HIV/AIDS Comprehensive Response Information System and the cases diagnosed with HIV/AIDS in Jingzhou during 1996-2021 and aged 15 years or older were selected for the study. The death curve was drawn with Kaplan-Meier method, and Cox proportional-hazards model was used to identify influencing factors for death.Results:A total of 3 304 HIV/AIDS cases were followed up for 16 091.5 person-years, and 893 cases died, with a case fatality rate of 5.5/100 person-years. The cumulative case fatality rates of 1, 5 and 10 years were 15.4%, 25.0% and 34.6% respectively, the cumulative case fatality rates of 1, 5 and 10 years were 6.9%, 14.4% and 23.7% in the cases with access to antiretroviral therapy (ART), and 68.0%, 90.1% and 98.7% in the cases without access to ART. The results of Cox proportional hazards regression model showed that the risk for death was higher in those without access to ART than in those with access to ART (a HR=9.85, 95% CI: 8.19-11.85). The risk factors for death in those with access to ART included being men (a HR=1.64, 95% CI: 1.29-2.08), age ≥60 years old at diagnosis (a HR=3.52, 95% CI: 2.38-5.20), being infected by injecting drug use/others (a HR=2.38, 95% CI:1.30-4.34), being detected by medical institution (a HR=1.53, 95% CI: 1.11-2.11), CD4 +T lymphocytes(CD4) counts <50 cells/μl (a HR=2.58, 95% CI: 1.87-3.58). The protective factor for death was high education level (high school and technical secondary school: a HR=0.64,95% CI:0.46-0.90; college and above: a HR=0.42, 95% CI: 0.24-0.73). The risk factors for HIV/AIDS death in those without access to ART included older age at diagnosis (30-44 years old: a HR=2.32, 95% CI: 1.40-3.84; 45-59 years old:a HR=2.61, 95% CI: 1.59-4.27; ≥60 years old: a HR=3.31, 95% CI: 2.01-5.47), lower CD4 counts (<50 cells/μl: a HR=10.47, 95% CI: 6.47-16.56; 50-199 cells/μl: a HR=2.31, 95% CI: 1.08-4.94; 200-349 cells/μl: a HR=2.35, 95% CI: 1.46-3.79). Conclusions:The case fatality rate of HIV/AIDS was relatively high in Jingzhou from 1996 to 2021, the first CD4 counts, ART and age at diagnosis were the major factors affecting HIV/AIDS death, "Expanding testing" and "prompt treatment upon diagnosis" should be continued and enhanced to improve the efficacy of ART and HIV/AIDS case survival.
9.Development, reliability and validity of the cultural competency assessment scale for geriatric nurse specialists
Shijie LYU ; Zhaoqi LIU ; Xiao ZHANG ; Yingxin CHEN ; Zheng SUN
Chinese Journal of Practical Nursing 2022;38(21):1613-1619
Objective:To develop a cultural competency assessment scale for geriatric clinical nurse specialists and test its reliability and validity.Methods:Through literature research, qualitative interviews, expert correspondence, and pretesting, the cultural competency assessment scale for geriatric clinical nurse specialists was developed. A total of 140 geriatric nurses from 8 tertiary hospitals in Beijing, Guizhou, Harbin, Shandong and Shaanxi from July to September 2021 were selected for the survey.Results:The final cultural competency assessment scale for geriatric clinical nurse specialists consisted of 4 dimensions of cultural knowledge, cultural awareness, cultural skills, and cultural interaction behaviors, with 31 entries, Cronbach α coefficient of 0.953 for the scale, Cronbach α coefficient of 0.875-0.974 for the 4 dimensions, and retest reliability of 0.925. I-CVI was 0.857-1.000, and the average S-CVI was 0.974. The cumulative contribution of the four common factors was 72.51%. Conclusions:The reliability and validity of the cultural competency assessment scale for geriatric clinical nurse specialists are good and can be used to evaluate the cultural competency of geriatric clinical nurse specialists.
10.Research progress on adverse effects of fine particulate matter constituent exposure on ischemic heart disease
Yingxin LI ; Ruijun XYU ; Hai ZHANG ; Lan ZHANG ; Hong SUN ; Yun ZHOU ; Yuewei LIU
Journal of Public Health and Preventive Medicine 2021;32(4):120-125
Ambient fine particulate matter (PM2.5) is a mixture consisting of a wide range of chemical constituents including carbonaceous aerosols, water soluble ions and inorganic elements, and has become the major air pollutant in most cities in China. Evidence suggests that exposure to ambient PM2.5 induces damage on the cardiovascular system and can increase risk of the development and mortality of ischemic heart diseases (IHD). However, the effects of exposure to specific PM2.5 constituents on IHD remain unclear, and its underlying mechanisms are yet to be investigated. Here we reviewed studies investigating the association of short- and long-term exposure to specific PM2.5 constituents with IHD, which may provide useful clues for future relevant studies.


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